Access and closure device and method

• US 7,998,169 B2
• Filed: 10/06/2006
• Issued: 08/16/2011
• Est. Priority Date: 05/12/2004
• Status: Active Grant

• Current Assignee: Arstasis, Inc.
• Original Assignee: Arstasis, Inc.
• Inventors: Modesitt, D. Bruce
• Primary Examiner(s): Erezo; Darwin P
• Assistant Examiner(s): RYCKMAN, MELISSA K
• Application Number:
  US11/544,177
• Publication Number:
  US 20070027454A1
• Time in Patent Office: 1,775 Days
• Field of Search: 606/213, 606/215, 606/216, 606/221, 604/164.01, 604/44, 604/158, 604/115
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/00676 promotion of self-sealing of the puncture
• CPC Class Codes: A61B 2017/0403 Dowels
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61M 2025/0002 : with a pressure sensor at the distal end
• CPC Class Codes: A61M 25/01 : Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/06 : Body-piercing guide needles or the like

Abstract

Devices and methods for accessing and closing vascular sites are disclosed. Self-sealing closure devices and methods are disclosed. A device that can make a steep and controlled access path into a vascular lumen is disclosed. Methods for using the device are also disclosed.

Claims

1. A method for forming a self-sealing arteriotomy using a device comprising first and second introducers, the method comprising:

a. advancing the first introducer, the first introducer having a distal portion coupled to an anchor, through a first arteriotomy that has a first angle with respect for the vessel wall to place the anchor into a lumen of the artery;

b. applying a force to the first introducer to position an adjacent portion of the artery wall in a desired contact configuration relative to the anchor;

c. while maintaining the lumen portion in the desired contact configuration with the anchor, advancing the second introducer through a portion of the first introducer and through the artery wall to form a tract within the artery wall that has a substantially lateral portion, as well as a distal portion that defines a second angle with respect to the vessel wall and wherein the first angle is larger than the second angle, and wherein the tract is defined between overlapping tissue portions of the artery wall;

d. advancing the second introducer into the lumen of the artery; and

e. expanding the tract with a sheath so that a procedure may be performed therethrough, wherein after the procedure has been performed and the device and sheath have been withdrawn from the tract, blood pressure acting on the artery causes the overlapping tissue portions to collapse and self-seal.

2. The method of claim 1, wherein the tract includes at least one sloped region.

3. The method of claim 1, wherein the second introducer has a preformed bend.

4. The method of claim 1, wherein the second introducer comprises a needle.

5. The method of claim 4, wherein the needle is hollow.

6. The method of claim 1, further comprising rotating the second introducer toward the lumen of the artery.

7. The method of claim 1, wherein expanding the tract with the sheath comprises further comprising inserting the an introducer sheath over the second introducer.

8. The method of claim 1, wherein the tract has a diameter of about 1.0 mm to about 10.2 mm.

9. The method of claim 1, wherein the first angle and the second angle define an introduction angle relative to each other.

10. The method of claim 9, wherein when the second introducer enters the lumen, the introduction angle is less than or equal to about 19°

.

11. The method of claim 9, wherein when the second introducer enters the lumen, the introduction angle is less than or equal to about 15°

.

12. The method of claim 9, wherein when the second introducer enters the lumen, the introduction angle is from about 5°

to about 10°

.

13. The method of claim 1, wherein the force is a proximal force configured to urge the anchor into contact against the vessel wall.

14. The method of claim 13, wherein desired contact configuration comprises one in which a portion of the anchor is aligned to be substantially parallel with a wall surface of the lumen of the artery.